# K081532: Pharmajet Needle-Free Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Pharmajet, Inc.
- Decided: Feb 26, 2009 after 269 days
- Product code: KZE (Injector, Fluid, Non-Electrically Powered)
- Device class: 2
- Regulation: 21 CFR 880.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920631 (1994). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041239: Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000, Genesis Medical Technology, Inc. (2004) Summary page 2.
- K960373: Biojector 2000 Model 1B02000, Bioject, Inc. (1997) Summary page 2.

## Most influential descendants
- K110456: Pharmajet 0.1 ML Intradermal Needle-Free Injection System (2011), 1 descendant of its own
- K121270: Bioject Needle-Free Injection Management System (2012), 0 descendants of its own
- K111517: Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati (2011), 0 descendants of its own

## Indications for use
The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults, and children. It can also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

Source page: https://510kreport.com/device/K081532
Methodology: https://510kreport.com/methodology